Wireless Medical Technologies: Navigating Government Regulation In The New Medical Age

By Regulatory & Government Affairs Group at Fish & Richardson

Unless regulatory issues are taken into account at the earliest stages of the research and development process, device manufacturers could find themselves investing significant time and resources in products for which they cannot obtain government approval. In the U.S., three federal agencies, the Federal Communications Commission (FCC), the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS), are charged with regulating wireless medical devices. This article provides a comprehensive analysis of this tri-partite federal regulatory structure in order to help manufacturers navigate the myriad of technical rules and policies enforced by agencies with different, and sometimes divergent, objectives.